Measuring Diaphragm Electrical Activity in Neonates Using a Smaller Inter-electrode Distance
Primary Purpose
Respiratory Distress Syndrome, Newborn, Infant, Premature
Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
NVR 4mm Edi catheter
Sponsored by
About this trial
This is an interventional device feasibility trial for Respiratory Distress Syndrome, Newborn focused on measuring Preterm Neonates, NAVA Ventilation
Eligibility Criteria
Inclusion Criteria:
- Neonates with current weight <750g who are already receiving invasive or non-invasive NAVA ventilatory support using the standard 6 mm IED Edi catheter will be eligible for recruitment.
Exclusion Criteria:
- Infants deemed to be unstable by the attending clinician from a respiratory or hemodynamic perspective
- Known congenital or chromosomal anomalies
- Any acute illness such as sepsis, necrotizing enterocolitis or acute pulmonary hypertension
- Parental consent not available
Sites / Locations
- Mount Sinai HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
NVR 4mm Edi Catheter
Arm Description
Outcomes
Primary Outcome Measures
Feasibility of re-initiating NAVA ventilation with new NVR 4mm Edi Catheter
Categorical (yes/no) - Feasibility will be defined as 4mm catheters picking up EDI signals and allowing initiation of NAVA ventilation as per the standard clinical practice. Cases where clinical team is unable to initiate NAVA, necessitating change back to 6 mm catheters will be termed non-feasible.
Secondary Outcome Measures
Full Information
NCT ID
NCT05427929
First Posted
June 16, 2022
Last Updated
March 27, 2023
Sponsor
Mount Sinai Hospital, Canada
Collaborators
Unity Health Toronto
1. Study Identification
Unique Protocol Identification Number
NCT05427929
Brief Title
Measuring Diaphragm Electrical Activity in Neonates Using a Smaller Inter-electrode Distance
Official Title
A Pilot Study of Measuring Diaphragm Electrical Activity in Neonates Using a Smaller Inter-electrode Distance
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 12, 2023 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
February 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mount Sinai Hospital, Canada
Collaborators
Unity Health Toronto
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Neurally Adjusted Ventilatory Assist (NAVA) is a mode of ventilation where the electrical activity of the diaphragm (EDI) - a signal representing the baby's respiratory drive - is used to control the timing and amount of assist provided. NAVA was introduced to the market in 2007 and since has been used in more than 40 countries.
In the current clinical practice, the Edi signal from the patient is captured with miniature sensors (the size of a hair) embedded in the wall of a specially designed naso/orogastric feeding tube. This FDA and Health Canada approved, commercially available catheter (Getinge, Solna, Sweden), is 6 Fr in size (outer diameter), 49 cm in length and has 8 pairs of sensors that are placed 6 mm apart (so-called inter electrode distance (IED) is 6 mm).
While no obvious side effects have been noted by clinicians, for the smallest of neonates, the currently used commercial catheter (size 6F, 49 cm long) may have 'excessive' post-array catheter length. In these neonates, typically those with weight < 750 grams, following the correct placement of catheter as per the electrode array positioning at gastro-esophageal junction, the feeding holes in the catheter may end at the level of distal stomach instead of the desirable mid-stomach location. The changing demographics of the patients in the Neonatal Intensive Care Units (NICU) has created a clinical need to redesign the currently used Edi catheter specifically to suit the smallest of patients, such that following adequate placement the feeding holes sit at the level of mid-stomach. Drs. Christer Sinderby and Jennifer Beck in Toronto, Canada, are the original designers of the 6 mm/49 cm currently used Edi catheter. These investigators (at St-Michael's Hospital, Toronto) in collaboration with their team at Neurovent Research Inc. (NVR) have re-designed and invented a new prototype of the current FDA-approved catheter specifically suited for use in extreme premature neonates. They have done so by reducing the interelectrode distance from the originally set 6 mm to 4 mm, which reduces the overall insertion depth to capture the same signal from the diaphragm. All other parameters are exactly same as the original catheter (6F, 49 cm long).
In this small feasibility study the investigators wish to provide a clinical proof of concept for the use of this newly designed prototype in 10 extremely premature neonates who are already receiving NAVA ventilation in the NICU.
Detailed Description
This is an unblinded pilot study to evaluate the performance of the new 4 mm IED. The procedures required for this evaluation include placement of the new NVR 4 mm Edi catheter, and ventilation in the NAVA mode. All these procedures are considered to have no significant additional risk. Supervision by a physician or respiratory therapist with expertise in Edi catheter and NAVA will be present, in line with the current clinical practice in the Mount Sinai NICU.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Distress Syndrome, Newborn, Infant, Premature
Keywords
Preterm Neonates, NAVA Ventilation
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
NVR 4mm Edi Catheter
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
NVR 4mm Edi catheter
Intervention Description
Receive NAVA ventilation using the newly designed NVR 4 mm Edi catheter
Primary Outcome Measure Information:
Title
Feasibility of re-initiating NAVA ventilation with new NVR 4mm Edi Catheter
Description
Categorical (yes/no) - Feasibility will be defined as 4mm catheters picking up EDI signals and allowing initiation of NAVA ventilation as per the standard clinical practice. Cases where clinical team is unable to initiate NAVA, necessitating change back to 6 mm catheters will be termed non-feasible.
Time Frame
During study catheter change (total study length = 2 hours during procedure)
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Neonates with current weight <1000g who are already receiving invasive or non-invasive NAVA ventilatory support using the standard 6 mm IED Edi catheter will be eligible for recruitment.
Exclusion Criteria:
Infants deemed to be unstable by the attending clinician from a respiratory or hemodynamic perspective
Known congenital or chromosomal anomalies
Any acute illness such as sepsis, necrotizing enterocolitis or acute pulmonary hypertension
Parental consent not available
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amish Jain, MD, PhD
Phone
416-586-4800
Ext
5459
Email
amish.jain@sinaihealth.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Laura Thomas, MSc
Phone
416-586-4800
Ext
2060
Email
laura.thomas@sinaihealth.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amish Jain
Organizational Affiliation
MOUNT SINAI HOSPITAL
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mount Sinai Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laura Thomas, MSc
Phone
416-586-4800
Ext
2060
Email
laura.thomas@sinaihealth.ca
First Name & Middle Initial & Last Name & Degree
Amish Jain, MD PhD
12. IPD Sharing Statement
Learn more about this trial
Measuring Diaphragm Electrical Activity in Neonates Using a Smaller Inter-electrode Distance
We'll reach out to this number within 24 hrs